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Sponsors and Collaborators: |
Heart Center Bad Krozingen Cordis, Johnson&Johnson company |
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Information provided by: | Heart Center Bad Krozingen |
ClinicalTrials.gov Identifier: | NCT00288535 |
This study is a prospective, randomized, single-center evaluation of the Cypher™ Sirolimus eluting coronary stent system in the treatment of de novo bifurcated coronary lesions comparing provisional modified T stenting with systematic modified T-stenting.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Procedure: PCI of bifurcated coronary lesions using sirolimus coated stents in modified T-Stenting -Technique |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective, Randomized, Single-Center Evaluation of the Cypher™ Sirolimus Eluting Coronary Stent System in the Treatment of Bifurcated Coronary Lesions |
Estimated Enrollment: | 200 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | February 2007 |
Bifurcations involving a significant side branch (SB diameter ≥ 2.25 mm) occur in approximately 15-20% of all coronary lesions considered for percutaneous intervention. If a side branch (SB) subtends significant myocardium, failure to preserve SB vessel patency can lead to complications such as myocardial infarction or persistent chest pain despite full patency of the main branch.
Bifurcation lesions are inherently complex and interventional treatment remains a challenging problem for physicians.
The optimal technique for stenting bifurcated lesions is still unknown. Several dual vessel stenting techniques have been described in the literature, such as "T", "V", "Y", "Culotte" and "Crush" procedures. However, most studies of bifurcation stenting have found that optimal long-term results are obtained by stenting the main vessel and then performing plain balloon angioplasty of the side branch ("kissing balloon"-technique). Nevertheless, occlusion or reduced flow of the SB are frequent after stenting of the MB. Therefore, the SB is stented in approximately 50% of procedures even if PTCA alone was intended.
Hypothesis:
Compared with plain dilatation of side branch, the placement of Cypher-Stent in side branch using modified T-stenting technique will reduce "in-segment percent diameter stenosis" of the side branch at 9 months post procedure as measured by quantitative coronary angiography.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. The target vessel must meet the following criteria:
The target vessel (main branch and side branch) must be feasible for stent implantation (successful passage with the guide wire; successful predilatation with an appropriately sized balloon; no heavy calcification; no diffuse distal disease that might impede run off).
2. Patient has stable or unstable angina pectoris (CCS classification I or greater) or a positive stress test for ischemia.
3. Patient must be ≥ 18 years of age. 4. Female subjects of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
5. Patient has no other treatment planned within 30 days of the procedure. 6. Patient has been informed of the nature of the study and agrees to its provisions and has written informed consent as approved by the Ethics Committee. 7. Patient willing to comply with required post-procedure follow-up.
Exclusion Criteria:
1. Patient has had an acute myocardial infarction (> 3x normal CK with presence of CKMB) within 72 hours preceding the index procedure and CK has not returned to normal limits at the time of the procedure. 2. Patient will have a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel, sirolimus, or contrast sensitivity that cannot be adequately pre-medicated. 3. Patient has a platelet count of <100,000 cells/mm³ or >700,000 cells/mm³, a WBC of <3,000 cells/mm³, or documented or suspected liver disease. 4. Patient has a history of bleeding diathesis or coagulopathy. 5. Patient has suffered a CVA or TIA within the past six months. 6. Active peptic ulcer or upper GI bleeding within the prior 6 months. 7. Patient has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life- expectancy (less than 2 years). 8. Patient must be excluded from the study if any of these angiographic criteria are met:
Contact: Miroslaw Ferenc, Dr. | 0049 7633 4020 | Miroslaw.Ferenc@herzzentrum.de |
Contact: Franz-Josef Neumann, Prof. Dr. | 0049 7633 4020 | Franz-Josef.Neumann@herzzentrum.de |
Germany, Suedring 15 | |
Herz-Zentrum Bad Krozingen | Recruiting |
Bad Krozingen, Suedring 15, Germany, 79189 | |
Contact: Miroslaw Ferenc, Dr. 0049 7633 4020 Miroslaw.Ferenc@herzzentrum.de | |
Contact: Franz-Josef Neumann, Prof. Dr. 0049 7633 4020 Franz-Josef.Neumann@herzzentrum.de |
Principal Investigator: | Miroslaw FERENC, Dr. | Haert Center Bad Krozingen; Germany |
Study Director: | Franz-Josef Neumann, Prof. Dr. | Heart Center Bad Krozingen, Germany |
Study ID Numbers: | HZ-BK-2005-1 |
Study First Received: | February 7, 2006 |
Last Updated: | September 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00288535 History of Changes |
Health Authority: | GERMANY: Ethik-Kommision der Albert-Ludwigs-Universitaet Freiburg |
coronary bifurcation ; PCI; modified T-Stenting; sirolimus stent |
Arterial Occlusive Diseases Sirolimus Heart Diseases Immunologic Factors Clotrimazole Myocardial Ischemia Miconazole Tioconazole |
Vascular Diseases Ischemia Arteriosclerosis Immunosuppressive Agents Coronary Disease Anti-Bacterial Agents Antifungal Agents Coronary Artery Disease |
Arterial Occlusive Diseases Sirolimus Anti-Infective Agents Heart Diseases Immunologic Factors Antineoplastic Agents Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases Arteriosclerosis |
Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Coronary Disease Anti-Bacterial Agents Antifungal Agents Therapeutic Uses Cardiovascular Diseases Coronary Artery Disease |